FDA Announces New Actions Expanding Use of Pfizer-BioNTech Vaccine
On Jan. 3, the U.S. Food and Drug Administration (FDA) announced multiple actions via a press release to expand the use of the Pfizer-BioNTech COVID-19 vaccine.
The release states that “Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to:
- Expand the use of a single booster dose to include use in individuals 12 through 15 years of age.
- Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months.
- Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.”
The release explains that the FDA has determined that the protective health benefits of a booster dose outweigh the potential risks in individuals aged 12 to 15 years.
“The FDA reviewed real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series,” the release continues.
That said, “These additional data enabled the FDA to reassess the benefits and risks of the use of a booster in the younger adolescent population in the setting of the current surge in COVID-19 cases. The data shows there are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals.”
The release adds that “No new safety concerns have emerged from a population of over 4.1 million individuals 16 years of age and older in Israel who received a booster dose at least five months following completion of the primary vaccination series.”
The release explains that authorizing booster vaccination to take place at five months vs. six months may provide better protection against the highly transmissible Omicron variant.
“Given the demonstrated safety and effectiveness of a booster dose when administered five months after the primary vaccination series, and the fact that a booster dose may help provide better protection against the rapidly spreading omicron variant, the FDA has determined that the known and potential benefits of administering a booster to individuals ages 12 and older at least five months following completion of the primary vaccination series, outweighs the known and potential risks,” the release states.
Regarding the third primary series dose for “certain immunocompromised children 5 through 11 years of age,” the release states that “Children 5 through 11 years of age who have undergone solid organ transplantation, or who have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise, may not respond adequately to the two-dose primary vaccination series. Thus, a third primary series dose has now been authorized for this group. This will now allow these children to receive the maximum potential benefit from vaccination.:
Acting FDA Commissioner Janet Woodcock, M.D. was quoted in the release saying that “Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind. With the current wave of the Omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing, and social distancing to in order to effectively fight COVID-19.”
